Randomized Placebo Controlled Clinical Study of an Oral Product in Subjects With Menopausal Symptoms

A Randomized, Placebo Controlled Clinical Study to Examine the Clinical Benefits of an Oral Product in Subjects With Menopausal Symptoms Including Vasomotor Symptoms

The objective of this study is to assess the safety and effectiveness of a dietary supplement for symptom relief in subjects with menopausal symptoms over the course of five weeks of continuous daily use.

Study Overview

• Status: Completed
• Conditions: Menopausal Symptoms
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Dietary Supplement with Proprietary Herbal Extract Blend and GABA

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94127
      • See Final Report

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy Females aged 40 to 65 years,
• Self-reporting menopausal symptoms (> 5 hot flushes per day) and have been present for a minimum of previous 60 days prior to baseline visit.
• Reporting a variable cycle length of > 7 days different from normal
• BMI 20-40 kg/m2
• Able to read, understand, and complete the study questionnaire and records.
• Able to understand the study procedures.
• Able to comply with all study requirements.
• Written informed consent to participate in the study.
• Willingness to actively participate in the study and to come to the scheduled visits.

Exclusion Criteria:

• Pregnancy or breastfeeding.
• Immune insufficiency
• Women of childbearing potential including those still having a menstrual cycle on a regular basis who are not perimenopausal, menopausal or post-menopausal.
• History of hysterectomy
• Women on hormone replacement therapy
• Use of systemic corticosteroids or immunosuppressant drugs.
• Other diseases or medications that might directly interfere in the study or put the subject's health under risk.
• Employees of the institute
• Cardiovascular-, chronic liver-, thyroid or kidney diseases; a history of cancer; a disease or condition that could influence the participants' ability to follow the study protocol,
• Alcohol or drug abuse,
• Use of hormonal contraceptives within the last 3 months
• BP ≥160/110 mmHg
• Oophorectomy or amenorrhea > two years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Eligible subjects will receive Placebo to take daily for five weeks
Active Comparator: Dietary Supplement with Actives	Dietary supplement: Dietary Supplement with Proprietary Herbal Extract Blend and GABA; Eligible subjects will receive active product to take daily for five weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of symptom scores in Daily Dairy	To assess changes in symptom scores attained from product use in subjects with menopausal symptoms, including acute effects	from enrollment to the end of study at five weeks
Changes of symptom scores in Mobile Application	To assess changes in symptom scores attained from product use in subjects with menopausal symptoms, including acute effects	from enrollment to the end of study at five weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Menopause-Specific Quality of Life (MENQOL) Scores	To assess changes in mood and quality of life scores of the product compared to placebo	from enrollment to the end of study at five weeks
Changes in Green Climacteric Scale (GCS) Scores	To assess changes in mood scores of the product compared to placebo	from enrollment to the end of study at five weeks
Changes in Perceived Stress Scale (PSS) Scores	To assess changes in mood scores of the product compared to placebo	from enrollment to the end of study at five weeks
Changes in Profile of Mood States (POMS) Scores	To assess changes in mood scores of the product compared to placebo	from enrollment to the end of study at five weeks
Changes in Pittsburgh Sleep Quality Index (PSQI) Scores	To assess changes in sleep scores of the product compared to placebo	from enrollment to the end of study at five weeks

Collaborators and Investigators

• Sponsor: Olly, PBC

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2024
• Primary Completion (Actual): June 24, 2024
• Study Completion (Actual): June 24, 2024

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: UNLV20240222

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No